Module 1 2021

Fast Track

 Fast Track is a process designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life threatening conditions fill an unmet medical need  Applies to the product and the indication  May be requested at any time during development. An applicant must submit a request ( 60 days review)  Emphasizes the close and early communication between the FDA and sponsor to improve the efficiency of product development  Benefits include − “Rolling submission" for a marketing application − More frequent meetings with FDA to discuss development plans and ensure collection of appropriate data needed to support approval − The option of requesting evaluation of studies using surrogate endpoints (Accelerated Approval)

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Priority Review

• Priority Review designation is given to drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists

• The goal for completing a priority review is 6 months (versus standard review period of 10 months)

• A request for priority review is made by the Sponsor at the time of the NDA filing, and the FDA will determine within 60 days whether a priority or standard review designation will be assigned

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